HealthTech Industry Update | 3D medical device manufacturing

Kurt Neubauer

Kurt Neubauer

Ricoh 3D for Healthcare produces patient-specific anatomic models via additive manufacturing, using segmented 3D print files created from medical images in FDA-cleared applications.

Standard compliant 3D printed anatomic models

Ricoh USA has announced in 2023 at the RSNA Assembly and Annual Meeting, a partnership with Materialise that will provide software solutions to support RICOH 3D for Healthcare – a HIPAA-compliant, ISO 13485 certified 3D medical manufacturing centre for the development, design and production of 3D-printed anatomic models – in both their centralised medical device manufacturing facility, as well as in Ricoh’s Point of Care facilities.

  • Through the partnership, Ricoh will be able to drive more personalised healthcare solutions and make it simple to create or expand on-site point-of-care centres.
  • With an uptick in 3D printing, hospitals are either now seeking to enter the market by establishing point-of-care centres onsite or scaling existing offerings.
  • A main driver of either option is co-located management of facilities and production through partners such as Ricoh with technologies like those from Materialise.
  • It is important for care providers to recognise that when these 3D-printed models and other instruments are used for patient care, they may be considered medical devices, subject to FDA regulation.
  • With RICOH 3D for Healthcare, hospitals can adopt or advance point-of-care manufacturing without the need to become an FDA registered medical device manufacturer, implement a quality management system, navigate regulatory requirements, or tackle the administrative aspects to support it all with a multidisciplinary team.

Ricoh offer democratised access to patient-specific 3D-printed models in healthcare:

  • Merge by Merative: Through an expanded partnership with Merge by Merative, hospitals and clinicians can access the RICOH 3D for Healthcare Platform via the new PACS Print Gateway.
  • The workflow will be initiated via a “Send to RICOH 3D” button that can be added to a variety of DICOM viewers. This will initiate the transfer of the appropriate DICOM study to a cloud-based vendor neutral archive. It will also activate the RICOH 3D for Healthcare Case Management Portal to manage the case in conjunction with the clinical team.
  • Stratasys: RICOH 3D for Healthcare engages in a strategic collaboration with Stratasys to leverage their 3D printing technology to expand access to 3D-printed medical models.

More info:

3D medical device manufacturing facility

Ricoh USA, Inc. has recently announced its flagship Point of Care 3D medical device manufacturing facility – the RICOH 3D for Healthcare Innovation Studio.

Through its mission to innovate and improve clinical outcomes and quality of life, Ricoh says the on-site Innovation Studio provides clinicians with easy and immediate access to development, design, and manufacturing services for patient-specific, 3D-printed anatomic models, which can be used for surgical planning and patient education.

Located in Innovation Quarter, in downtown Winston-Salem, N.C., it is the first of many Point of Care 3D medical device manufacturing facilities that will be connected to a health system.

FDA-cleared applications

These models are used for diagnostic purposes in various medical fields, including craniomaxillofacial, orthopedic, cardiovascular, neurological, gastrointestinal, genitourinary, and breast applications.

With the ability to manage 3D-print operations at the point of care, the RICOH 3D for Healthcare Innovation Studio gives providers access to a streamlined and efficient solution for producing and obtaining these models. The new facility enables Atrium Health Wake Forest Baptist and Wake Forest University School of Medicine to create a Medical 3D Printing Center of Excellence, in collaboration with Wake Forest Innovations and Innovation Quarter.

In patient care, access to precision, anatomic 3D models from on-site facilities like the RICOH 3D for Healthcare Innovation Studio allows clinical teams to plan and provide timely and informed care plans. It may also lead to:

  • Reduced operating times – Surgeons using 3D-printed anatomic models saw an average operation time savings of 62 minutes and a 7.8% reduction in operative time
  • Redefined surgical approaches – 50% of surgeons redefined their surgical approach when a 3D model was used during the planning stage
  • Lowered costs – When used for diagnostic purposes, providers saw an average cost savings of $3,720 per case
  • Educational opportunities – 3D-printed models offer cadaver-free training, clearer communication, and education for patients when discussing informed consent
  • Enhanced diagnostic support – Having accurate insights into a patient’s anatomy beforehand allows clinicians to better evaluate and understand complex conditions to effectively prepare a more informed approach to procedures and care
  • Decreased compliance concerns – With an on-site Point of Care 3D medical device manufacturing facility, regulatory and legal compliance requirements are met due to Ricoh’s award-winning Managed Services platform, 3D-printing expertise and FDA 510(k)-cleared anatomic models

For further information have a look on the full article(s) by  MED-TECH INNOVATION | NEWS:

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